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Photodynamic Therapy for COVID-19 Prevention

NCT05184205 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2022-08-12

No results posted yet for this study

Summary

This is a single-center open-label study to evaluate antimicrobial photodynamic therapy (aPDT) for upper airway decolonization in patients presenting with SARS-CoV-2 positive antigen test with mild or no symptoms of COVID-19.

Conditions

  • COVID-19 Respiratory Infection
  • SARS-CoV-2 Acute Respiratory Disease

Interventions

DEVICE

Nasal Photodisinfection

The procedure is initiated by swabbing the Formulation Applicator, pre-saturated with photosensitizer formulation, inside the patient's nares. The operator then connects the Nasal Light Illuminator (NLI) to the Light Source and inserts the NLIs into the patient's nostrils. The Light Source is turned on, and a 4-minute illumination cycle provides two channels of diffused red light (one for each nostril) to activate the applied formulation. Illumination stops automatically upon completion of the 4-minute cycle. The process is then repeated using two new Formulation Applicators to ensure full disinfection coverage.

DEVICE

Sham Comparator: Control

Patients who are SARS-CoV-2 positive whose PCR levels are followed but no active intervention will be done. Saline will be used in their nose and the light device will be inserted but not turned on. Patient will be wearing light protecting glasses.

Sponsors & Collaborators

  • University of Navarra

    collaborator OTHER

  • Ondine Biomedical Inc.

    lead INDUSTRY

Principal Investigators

  • Josepmaria Argemi, MD · Clinica Universidad de Navarra

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-12-20
Primary Completion
2022-04-30
Completion
2022-05-30

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05184205 on ClinicalTrials.gov